Forceps Cliprack Ventricular Cannula Saws Spatulas
FDA 510(k) K874962 · Solway, Inc.
510(k) numberK874962
Submission
- Device name
- Forceps Cliprack Ventricular Cannula Saws Spatulas
- Applicant
- Solway, Inc.
Hollywood, FL, US - Received
- December 2, 1987
- Decision date
- February 2, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code HAO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220920 | Matreneu Percutaneous Balloon Compression KitHAO · Traditional | Shenzhen Shineyard Medical Device Co. , Ltd. | 09/07/2022SE |
| K940973 | Mullan Ganglion Microcompression SetHAO · Traditional | Cook, Inc. | 09/29/1995SE |
| K951492 | Rib ResectorHAO · Traditional | United States Surgical, A Division of Tyco Healthc | 05/18/1995SE |
| K943115 | Auto Suture Pituitary Spinal RongeurHAO · Traditional | United States Surgical, A Division of Tyco Healthc | 07/25/1994SE |
| K942971 | Auto Suture Spinal DissectorHAO · Traditional | United States Surgical, A Division of Tyco Healthc | 07/20/1994SE |
| K942970 | Auto Suture Spinal ElevatorHAO · Traditional | United States Surgical, A Division of Tyco Healthc | 07/20/1994SE |
| K942969 | Auto Suture Spinal Nerve HookHAO · Traditional | United States Surgical, A Division of Tyco Healthc | 07/20/1994SE |
| K942968 | Auto Suture Spinal OsteotomeHAO · Traditional | United States Surgical, A Division of Tyco Healthc | 07/20/1994SE |
| K942967 | Auto Suture Spinal CuretteHAO · Traditional | United States Surgical, A Division of Tyco Healthc | 07/20/1994SE |
| K923723 | Silicone Brain Spatula SetHAO · Traditional | Redmond Neurosurgical, Inc. | 08/12/1992SE |
More from Redmond Neurosurgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K874960 | Cardiovascular Surgical InstrumentsDWS · Traditional | 02/05/1988SE |
| K874956 | Self-Retaining Retractor for NeurosurgeryGZT · Traditional | 01/28/1988SE |
| K874964 | Dental Hand InstrumentsEKJ · Traditional | 01/27/1988SE |
| K875043 | Rongeur (Neurosurgical Instruments)HAE · Traditional | 01/22/1988SE |
| K874966 | Tuning ForksGWX · Traditional | 01/04/1988SE |
| K874965 | Manual Surgical Instruments for General UseHTD · Traditional | 12/30/1987SE |
| K874961 | Bone Cutting Instruments & AccessoriesGDR · Traditional | 12/30/1987SE |
| K874959 | Vascular ClampHXD · Traditional | 12/30/1987SE |
| K874954 | Manual RongeurHTX · Traditional | 12/30/1987SE |
| K874952 | Manual Cranial Drill, Burr, Trephine & AccessoriesHBG · Traditional | 12/30/1987SE |
Questions and answers
When was Forceps Cliprack Ventricular Cannula Saws Spatulas cleared by the FDA?
Forceps Cliprack Ventricular Cannula Saws Spatulas (K874962) received a 510(k) decision of Substantially Equivalent on February 2, 1988, 62 days after the submission was received.
What is the product code of K874962?
The FDA product code is HAO – Instrument, Surgical, Non-Powered, a Class I (low risk) device regulated under 21 CFR 882.4535.